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DRUG CLASS:

CD22-targeted antibody-drug conjugate

5d
Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO) (clinicaltrials.gov)
P2, N=25, Recruiting, University of Chicago | Suspended --> Recruiting | Trial completion date: Mar 2027 --> Mar 2028 | Trial primary completion date: Mar 2027 --> Mar 2028
Enrollment open • Trial completion date • Trial primary completion date
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD22 (CD22 Molecule)
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dasatinib • Iclusig (ponatinib) • methotrexate • Besponsa (inotuzumab ozogamicin) • vincristine • mercaptopurine
24d
Impact of Blinatumomab and Inotuzumab Exposure on Apheresis Composition for CAR T in Patients With B-cell Acute Lymphoblastic Leukemia. (PubMed, Cytotherapy)
There were no other notable differences in T-cell phenotype or markers of exhaustion among the subset of samples with extended flow cytometry panels. With the exception of lower CD4:CD8 ratios in patients with prior inotuzumab, the comparable apheresis yield and composition observed after immunotherapy exposure is a reassuring finding, particularly in light increased use of upfront blinatumomab for B-ALL.
Journal • IO biomarker
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CD8 (cluster of differentiation 8) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • NCAM1 (Neural cell adhesion molecule 1)
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Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
24d
Lymphoid blast crisis in chronic myeloid leukemia after long-term treatment-free remission following imatinib treatment (PubMed, Rinsho Ketsueki)
The patient achieved complete hematological remission after one cycle of dasatinib combined with hyper-CVAD/MA. Measurable residual disease persisted, and he underwent two cycles of inotuzumab ozogamicin therapy followed by allogeneic hematopoietic stem cell transplantation. This case highlights the critical need for vigilant follow-up in CML patients after prolonged TFR, given the risk of progression to blast crisis.
Journal
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ABL1 (ABL proto-oncogene 1)
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dasatinib • imatinib • Besponsa (inotuzumab ozogamicin)
1m
Targeting drug efflux and DNA repair enhances inotuzumab ozogamicin activity in IO-resistant B-ALL cell lines. (PubMed, Int J Hematol)
Notably, in the triplet combination of IO with P-gp and PARP inhibitors, PARP inhibition of the repair of DNA damage caused by calicheamicin accumulation following P-gp inhibition markedly enhanced the antitumor effects of IO. This approach may offer a novel and effective therapeutic strategy for IO-resistant B-ALL.
Preclinical • Journal • PARP Biomarker
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ABCB1 (ATP Binding Cassette Subfamily B Member 1)
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Besponsa (inotuzumab ozogamicin)
1m
Trial initiation date
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CD22 (CD22 Molecule)
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CD19 positive • CD22 positive
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Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
2ms
Retrospective analysis of inotuzumab-associated hepatotoxicity in adult patients with B-cell acute lymphoblastic leukemia: Expanding the Spectrum of calicheamicin syndrome. (PubMed, J Oncol Pharm Pract)
Median time to hepatotoxicity improvement after InO discontinuation was 18 days, and no patients progressed to SOS.ConclusionCalicheamicin Syndrome represents a reproducible and reversible hepatotoxic entity distinct from SOS, characterized by InO exposure, transaminitis, thrombocytopenia, abnormal hepatic imaging, and HSC on pathology. Early recognition may facilitate monitoring and prevent progression to severe hepatic injury.
Retrospective data • Journal
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CD22 (CD22 Molecule)
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Besponsa (inotuzumab ozogamicin)
2ms
Testing the Combination of Inotuzumab Ozogamicin and Lower Dose Chemotherapy Compared to Usual Chemotherapy for Adults With B-Cell Acute Lymphoblastic Leukemia or B-Cell Lymphoblastic Lymphoma (clinicaltrials.gov)
P2, N=68, Active, not recruiting, Alliance for Clinical Trials in Oncology | Trial completion date: May 2028 --> May 2029 | Trial primary completion date: May 2026 --> Apr 2027
Trial completion date • Trial primary completion date
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CD20 (Membrane Spanning 4-Domains A1) • CD22 (CD22 Molecule)
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CD22 positive
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clonoSEQ®
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Rituxan (rituximab) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • methotrexate • Besponsa (inotuzumab ozogamicin) • vincristine • prednisone • mercaptopurine • dexamethasone injection
2ms
Trial initiation date
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CD22 (CD22 Molecule)
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CD22 positive
2ms
Trial suspension
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD22 (CD22 Molecule)
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dasatinib • Iclusig (ponatinib) • Besponsa (inotuzumab ozogamicin) • vincristine
2ms
Enrollment change
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD22 (CD22 Molecule)
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CD22 positive
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Iclusig (ponatinib) • Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
3ms
New P3 trial
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CD22 (CD22 Molecule)
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CD19 positive • CD22 positive
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Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
3ms
Ph-Negative Acute Lymphoblastic Leukemia in the Older Adults: Biology, Therapeutic Strategies and Unmet Needs. (PubMed, Eur J Haematol)
In this context, monoclonal antibodies such as blinatumomab and inotuzumab ozogamicin (InO), used alone or in combination with reduced-intensity chemotherapy, have emerged as promising frontline approaches capable of deep remissions with improved tolerability. Across all treatment strategies, comprehensive geriatric assessment appears more informative than performance status alone in predicting tolerability and outcome, supporting its integration into trial design and routine decision-making. Overall, the refinement of immunotherapeutic approaches, coupled with biologically and geriatrically tailored treatment algorithms, offers the most promising avenue to improve long-term outcomes for older patients with ALL.
Review • Journal • IO biomarker
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TP53 (Tumor protein P53)
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TP53 mutation
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Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)